Spain, through the European Union route · Notified bodies · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
8 requirements
Application fee
-
Class IIa devices need a notified body. The usual route is a quality management system audit with assessment of the technical documentation for at least one representative device per category. An alternative route combines technical documentation with product conformity verification. Class IIa medical devices, including many software products under Rule 11.
1. Technical documentation and quality system; 2. Application to a notified body; 3. Notified body assessment; 4. Certificate issued; 5. Declaration of conformity, CE mark and registration.
Outcome: Notified body certificate, then the maker's EU declaration of conformity and CE marking.
Legal basis: Regulation (EU) 2017/745, Article 52(6); Annexes IX and XI
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Spain: Class I devices: maker's declaration of conformity, Class I sterile, measuring or reusable surgical devices, Class IIb devices: notified body conformity assessment, Class III devices: notified body conformity assessment, Medical device software: qualification, classification and conformity assessment, Device with an ancillary medicinal substance: medicines authority consultation, Class C IVDs: notified body conformity assessment. See all routes on the Spain page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.